EU Revises CLP Regulation on Substances and Mixtures

SafeGuardSToys and Juvenile Products, Automotive, Cosmetics and Hygiene, Electrical & Electronics, Hardgoods, Personal and Protective Equipment, SoftlinesDec 04, 2024

SG 169/24

On November 20, 2024, the European Union (EU) issued Regulation (EU) 2024/2856 of October 23, 2024, to amend Regulation (EC) No 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP Regulation, consolidated version to December 2023, SafeGuardS 6/24 and 155/24).

This comprehensive amendment corresponds to globalization, technological developments and new means of sale, such as online sales.

Highlights of several provisions in the amendment are summarized in Table 1.

Section to CLP Regulation as amended by Regulation (EU) 2024/2856	Highlights
Article 2 ‘Definitions’	Includes definitions for 1) acute toxicity estimates, 2) data carrier, 3) refill and 4) refill station
Article 4 ‘General obligations to classify, label and package’	Unless a harmonized classification applies to a specific form or physical state of a substance, the general obligation applies to all its forms or physical states
Article 5 ‘Identification and examination of available information on substances’	Defines requirements for the evaluation of a substance containing more than one constituent in relation to the following: The ‘germ cell mutagenicity’, ‘carcinogenicity’, ‘reproductive toxicity’, ‘endocrine disruption for human health (ED HH)’ and ‘endocrine disruption for the environment (ED ENV)’ hazard classes The biodegradation, persistence, mobility and bioaccumulation properties within the ‘hazardous to the aquatic environment’, ‘persistent, bio-accumulative and toxic (PBT) or very persistent, very bio-accumulative (vPvB) properties’ and ‘persistent, mobile and toxic (PMT) or very persistent, very mobile (vPvM) properties’ hazard classes
Article 6 ‘Identification and examination of available information on mixtures’	Specifies criteria for the evaluation of a mixture with defined hazard classes
Article 10 ‘Concentration limits and M-factors for classification of substances and mixture’	Updates requirements
Article 13 ‘Decision to classify substances and mixtures’	Revises requirements
Article 23 ‘Derogations from labeling requirements for special cases’	Clarifies that the specific provisions for labeling under section 1.3 to Annex I apply to ammunition (Directive (EU) 2021/555), unless it is an article
Article 29 ‘Exemptions from labeling and packaging requirements’	Exempts packaging of ammunition for defense forces from labeling requirements under Article 17 (1)
Article 30 ‘Updating information on labels’	Unless a date has been defined for a change in the harmonized classification and labeling of a substance in a delegated act, labels are obliged to be revised within 6 or 18 months when the classification or labeling of a substance or mixture has been amended
Article 31 ‘General rules for the application of labels’	Allows labels in the form of a fold-out label to be firmly affixed to one or more surfaces of the packaging immediately containing the substance or mixture Defines criteria for digital labels (Article 34a(1)), including in a manner where it can be automatically processed by digital devices that are widely used. The data carrier must be accompanied by the statement ‘More hazard information available online’ or by a similar indication
Article 34a ‘Physical and digital labeling’	Requires label elements for substances and mixtures under Article 17 to be provided on a ‘physical label’ and additionally, may be provided on a ‘digital label’
Article 34b ‘Requirements for digital labeling’	Defines general rules and technical requirements for a digital label
Article 36 ‘Harmonization of classification and labeling of substances’	Expands hazard categories to include: Respiratory sensitization, category 1, 1A or 1B ED HH category 1 or 2 ED ENV category 1 or 2 PBT, vPvB, PMT and vPvM
Article 37 ‘Procedure for harmonization of classification and labeling of substances’	Revises procedure in relation to proposal for harmonized classification and labeling of a substance or group of substances
Article 48 ‘Advertisement’	Amends language for advertisement of a substance or mixture classified as hazardous
Article 48a ‘Distance sales offers’	New section indicating criteria for placing substances or mixtures on the market through distance sales
Article 53 ‘Adaptations to technical and scientific progress’	Authorizes Commission to adopt delegated acts to include elements that may be placed on a digital label only, subject to such elements are not required to appear on the physical label under GHS
Article 61 ‘Transitional provisions’	Defines compliance dates for classification, labeling and packaging of substances and mixtures in accordance with this amendment for substances and mixtures meeting specific provisions and which were placed on the market before certain dates
Annex I Part 1 ‘General principles for classification and labeling’	Revises Table 1.3 ‘Minimum dimensions of labels and pictograms’: Replaces package capacity of no more than three liters (3L) with two categories Introduces font size (height) requirements for all categories of package capacity (see Table 2 below) Defines characteristics for text on label Stipulates requirements for elements in fold-out labels Updates conditions for labeling of inner packaging where the contents do not exceed 10 mL (section 1.5.2.4.1)
Annex II Part 3 ‘Special rules on packaging’	New section 3.4 ‘Supply via refill stations’

Table 1

Package capacity (X)	Dimension of label for information under Article 17 (mm)	Dimension of each pictogram (mm)	Minimum font size (height in mm)
X ≤ 0.5L	At least 52 x 74 if possible	At least 16 x 16 if possible, otherwise no smaller than 10 x 10	1.2
0.5L < X ≤ 3L	At least 52 x 74 if possible	At least 16 x 16 if possible, otherwise no smaller than 10 x 10	1.4
3L < X ≤ 50L	At least 74 x 105	At least 23 x 23	1.8
50L < X ≤ 500L	At least 105 x 148	At least 32 x 32	2.0
X > 500L	At least 148 x 210	At least 46 x 46	2.0

Table 2

Regulation (EU) 2024/2865 will enter into force on December 10, 2024, which is 20 days after its publication in the Official Journal of the EU. Certain provisions in this amendment will be implemented in phases, starting from July 1, 2026.

At SGS, our safety data sheet services monitor all changes to the safety data sheet and we are ready to help you comply with all the challenges of REACH and CLP implementation and compliance. Our specialists have built up unique expertise in SDS over 15 years and are supported by dedicated software systems and comprehensive databases. These are in turn underpinned by up-to-the-minute market intelligence obtained through European Commission work groups, industrial federations and national authorities. Check our website or contact us to find out more about how SGS can help you achieve full compliance on safety data sheets, classification and labeling. In the end, it’s only trusted because it’s tested.

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